A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing

NCT04750005 | Completed Phase 4

• 1 other identifier: CCSORC002906
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of brushing, flossing, and rinsing with an alcohol containing essential oil mouth rinse; brushing and flossing; versus brushing and rinsing with an alcohol containing essential oil mouth rinse; and brushing only for the prevention and reduction of plaque and gingivitis.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use

  Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal \[absence of inflammation\]), 1 (Mild inflammation \[slight change in color, little change in texture\] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation \[moderate glazing, redness, edema, and/or hypertrophy\] of the gingival unit); 4 (Severe inflammation \[marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration\] of the gingival unit).

  12 Weeks

• Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use

  Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter \[mm\]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).

  12 Weeks

Secondary Outcomes (8)

• Marginal and Interproximal Mean Turesky Plaque Index (TPI) Score After 4 and 12 Weeks of Product use

  4 Weeks and 12 Weeks

• Marginal and Interproximal Mean Modified Gingival Index (MGI) Score After 4 and 12 Weeks of Product use

  4 Weeks and 12 Weeks

• Marginal Mean Expanded Bleeding Index (EBI) Score After 4 and 12 Weeks of Product use

  4 Weeks and 12 Weeks

• Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use

  4 Weeks

• Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use

  4 Weeks

Study Arms (4)

Brush only Group

ACTIVE COMPARATOR

Participants assigned to this group will brush their teeth using soft bristled toothbrush and colgate cavity protection toothpaste as directed under virtual supervision once daily during the week. Participants will brush second time unsupervised daily in the evening and twice daily over the weekend/holidays at home.

Other: Colgate Cavity Protection Toothpaste; Other: American Dental Association (ADA) Ref Toothbrush

Brush/Rinse Group

EXPERIMENTAL

Participants assigned to this group will perform their regimen (brushing \[soft bristled toothbrush and colgate cavity protection toothpaste\] and rinsing \[listerine cool mint antiseptic mouthwash\]) as directed under virtual supervision once daily during the week. Participants will brush and rinse a second time unsupervised daily in the evening at home. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over the weekend/holidays. First product use will occur at the site under supervision.

Other: Listerine Cool Mint; Other: Colgate Cavity Protection Toothpaste; Other: American Dental Association (ADA) Ref Toothbrush

Brush/Floss Group

EXPERIMENTAL

Participants assigned to this group will perform their regimen (brushing and flossing) as directed under virtual supervision once daily during the week. At home, participants will brush a second time unsupervised daily in the evening. Over the weekend and holidays, participants will brush and floss once daily. Only brushing will be performed a second time in the evening. First product use will occur at the site under supervision.

Other: Colgate Cavity Protection Toothpaste; Other: Reach Unflavored Waxed Dental Floss; Other: American Dental Association (ADA) Ref Toothbrush

Brush/Floss/Rinse Group

EXPERIMENTAL

Participants assigned to this group will perform their regimen (brushing \[soft bristled toothbrush and colgate cavity protection toothpaste\], flossing \[reach unflavored waxed dental floss\] and rinsing \[listerine cool mint antiseptic mouthwash\]) as directed under virtual supervision once daily during the week. Participants will brush and rinse a second time unsupervised daily in the evening. Over the weekend and holidays, participants will brush, floss and rinse once daily. Only brushing and rinsing will be performed a second time in the evening at home.

Other: Listerine Cool Mint; Other: Colgate Cavity Protection Toothpaste; Other: Reach Unflavored Waxed Dental Floss; Other: American Dental Association (ADA) Ref Toothbrush

Interventions

Listerine Cool Mint OTHER

Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.

Brush/Floss/Rinse Group; Brush/Rinse Group

Colgate Cavity Protection Toothpaste OTHER

Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

Brush only Group; Brush/Floss Group; Brush/Floss/Rinse Group; Brush/Rinse Group

Reach Unflavored Waxed Dental Floss OTHER

Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.

Brush/Floss Group; Brush/Floss/Rinse Group

American Dental Association (ADA) Ref Toothbrush OTHER

Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.

Brush only Group; Brush/Floss Group; Brush/Floss/Rinse Group; Brush/Rinse Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read and understand (participants capable of reading the documents)
• Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
• Negative pregnancy urine tests (females of childbearing potential only)
• Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
• A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
• A minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (BI)
• Participants will have evidence of some gingivitis; there will be no minimum or maximum mean MGI score for gingivitis or TPI score for plaque; mild to severe gingivitis and mild to moderate periodontitis
• No more than 3 sites having pocket depths of 5 millimeter (mm) and no sites that are greater than 5 mm in depth

You may not qualify if:

• History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products)
• Dental prophylaxis within four weeks prior to Screening/Baseline visit
• History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
• Use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
• Suspected alcohol or substance abuse (example., amphetamines, benzodiazepines, cocaine, marijuana, opiates

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (11)

• Rich SK, Friedman JA, Schultz LA. Effects of flossing on plaque and gingivitis in third grade schoolchildren. J Public Health Dent. 1989 Spring;49(2):73-7. doi: 10.1111/j.1752-7325.1989.tb02029.x.

  PMID: 2709366 BACKGROUND

• Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

  PMID: 5264376 BACKGROUND

• Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.

  PMID: 3485495 BACKGROUND

• CHILTON NW. Studies in the design and analysis of dental experiments. II. A four-way analysis of variance. J Dent Res. 1960 Mar-Apr;39:344-60. doi: 10.1177/00220345600390021601. No abstract available.

  PMID: 13809868 BACKGROUND

• Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x.

  PMID: 2524573 BACKGROUND

• Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.

  PMID: 7806674 BACKGROUND

• Benson BJ, Henyon G, Grossman E. Clinical plaque removal efficacy of three toothbrushes. J Clin Dent. 1993;4(1):21-5.

  PMID: 8357508 BACKGROUND

• Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.

  BACKGROUND

• Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.

  PMID: 12691269 BACKGROUND

• Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. doi: 10.14219/jada.archive.2004.0217.

  PMID: 15127875 BACKGROUND

• Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.

  PMID: 12699051 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

American Dental Association

Intervention Hierarchy (Ancestors)

Societies, Dental; Societies; Organizations; Health Care Economics and Organizations

Study Officials

• Jeffery Milleman, DDS

  Salus Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: October 23, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)